(1)
AQUEOUS AND NON-AQUEOUS MATRICES.
(a) If a
laboratory does not meet the acceptance limits for an analyte or analyte group
and the laboratory does not have acceptable results on a previous sample
analyzed during the same accreditation period, the laboratory shall analyze a
second PT sample for that analyte or analyte group.
(b) If the results of a second PT sample do
not meet the acceptance limits, the department may initiate an assessment of
the laboratory's quality control records if this action is necessary to
validate data generated by the laboratory. If two consecutive PT samples do not
meet acceptance limits, the laboratory shall do all the following:
1. Prepare a corrective action report and
initiate an action plan to correct the problems within 30 days of the date of
notification of the second failure. This action plan shall include a timetable
for correcting the problems and obtaining a third PT sample.
2. Analyze a third PT sample within 60 days
of the date of notification of the second failure. If the results of the third
PT sample do not meet the acceptance limits, the laboratory shall analyze two
subsequent and consecutive acceptable PT samples.
(c) The department may not renew
accreditation of those ana-lytes or analyte groups for which a laboratory has
failed three consecutive PT samples and has not successfully analyzed two
subsequent and consecutive PT samples for those analytes or analyte groups
prior to September 1.
(d) When
applying to have an analyte or analyte group reinstated after non-renewal for
failing three consecutive PT samples, the laboratory shall provide acceptable
results on two subsequent and consecutive PT sample studies for that analyte or
analyte group. The consecutive PT samples shall be two unique studies received
by the laboratory at least ten business days apart. The laboratory may not
prepare or analyze the two PT samples in the same batch.
(2) DRINKING WATER. If a certified laboratory
does not meet the acceptance limits that have been established by the
department, the department shall require the laboratory to analyze a second PT
sample and may require the laboratory to submit a corrective action report. If
the results of the second sample do not meet the acceptance limits, the
department may not renew the laboratory's certification and may revoke the
laboratory's certification as specified in s.
NR 149.10. To reinstate the certification for the
affected method-analyte or analyte group, the laboratory shall submit a revised
application, pay the revised application fee, and provide acceptable results on
two subsequent and consecutive PT sample studies for that method-analyte or
analyte group. The consecutive PT samples shall be two unique studies received
by the laboratory at least ten business days apart. The laboratory may not
prepare or analyze the two PT samples in the same batch.
